Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Rotator Cuff Rehabilitation Using BFR | Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation using blood flow restriction cuffs. 1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy using blood flow restriction cuffs. 2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy using blood flow restriction cuffs. Blood Flow Restriction Therapy: Blood flow restriction cuffs which are FDA approved will be provided to patients randomized into the BFR group. Patients will be provided video instruction and training on how to conduct the traditional therapy exercises with the use of BFR. | 0 | None | 0 | 15 | 0 | 15 | View |
| Rotator Cuff Rehabilitation Without BFR | Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation without using blood flow restriction cuffs. 1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy without using blood flow restriction cuffs. 2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy without using blood flow restriction cuffs. Traditional Therapy: Patients will be provided video instruction and training on how to conduct the traditional therapy exercises. | 0 | None | 0 | 15 | 0 | 15 | View |